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Perspectives on Heterogeneity in Health Care Lewis G. Sandy MD FACP
―The Myth of Average: Why Individual Differences Matter‖
November 30, 2012
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© 2012 UnitedHealth Group. Any use, copying or distribution without written permission from UnitedHealth Group is prohibited.
A Snapshot of the US Health Care System: July 19, 2012 (Part 1)
Genetic Aberrations Seen as Path to Stop Colon Cancer
By GINA KOLATA
More than 200 researchers investigating colon cancer tumors have found genetic vulnerabilities that could lead to powerful new treatments. The hope is that drugs designed to strike these weak spots will eventually stop a cancer that is now almost inevitably fatal once it has spread.
The colon cancer study, published on Wednesday in Nature, is the first part of a sweeping effort that is expected to produce a flood of discoveries for a wide range of cancers. The colon cancer findings will soon be followed by studies of lung and breast cancers and, later this year, of acute myeloid leukemia. The effort, the $100-million-a-year Cancer Genome Atlas project, is being financed by two government agencies, the National Cancer Institute and the National Human Genome Research Institute.
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A Snapshot of the US Health Care System: July 19, 2012 (Part 2)
After Boy’s Death, Hospital Alters Discharging Procedures
By JIM DWYER
NYU Langone Medical Center announced on Wednesday significant changes in its procedures after the death by septic shock of a 12-year-old boy who was sent home from the center with fever and a rapid heart rate.
Three hours after the boy, Rory Staunton, left the emergency room, a laboratory test showed that his blood had extraordinarily high levels of cells associated with bacterial infections. He subsequently went into shock and experienced organ failure, and died three days later, on April 1. His parents said they were not told about the lab results and were unaware of how seriously ill their son was, having been assured that he was suffering from a typical stomach bug.
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―Critical information gathered by his
family doctor and during his first visit to
NYU Langone was not used, was not at
hand or was not viewed as important
when decisions were made about his
care, records show.‖
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“Nobody said anything that
night,” Ms. Staunton said.
“None of you followed up the
next day on that kid, and he’s at
home, dying on the couch?”
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The Context: Scientific
Accelerating ease and lower cost of human genome sequencing, SNP genotyping and DNA analysis via microarrays
Explosive growth in correlation analysis in molecular medicine
Increased appreciation of: HTE (heterogeneity of treatment effects) in traditional RCTs and throughout EBM; gene/environment interactions;
Other disciples connecting to molecular medicine: Bioinformatics, Computational Biology, POC Diagnostics, Wireless Medicine
Clinical Applications are emerging, notably in Oncology, Transplant, Pharmacogenomics
Source: NATURE | VOL 487 | 19 JULY 2012
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The Increasing Complexity of the Central Dogma of Molecular Biology
Source: Feero WG et al. N Engl J Med 2010;362:2001-2011.
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―Healthcare is Riding on a Broken Chassis – Only a comprehensive program can fix it…‖ (March 2001)
SIX AIMS FOR
IMPROVEMENT
1. Safe
2. Effective
3. Patient-Centered
4. Timely
5. Efficient
6. Equitable
EFFECTIVE ORGANIZATIONAL SUPPORT
• Invest in Information Technology
• Coordinate Care
• Redesign Care Processes
• Manage Knowledge and Skills
• Develop Effective Multidisciplinary Teams
• Measure and Improve Performance and Outcomes
TEN RULES TO GUIDE
THE REDESIGN OF CARE
• Continuous Healing Relationships
• Evidence Based Decisions
• Customized Care
• Patient as Source of Control
• Shared Knowledge
• Transparency
• Safety as a System Property
• Cooperation Among Clinicians
• Needs are Anticipated
• Waste is Decreased
The IOM calls for
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Variation Across Markets in Episode Costs and Care Quality for Cardiac Catheterization (Diagnostic)
Note: Data includes only physicians designated as providing higher-quality care.
Source: Ellis P, Sandy LG et al Health Aff September
2012 vol. 31 no. 9 2084-2093
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Le
ve
l o
f F
inan
cia
l R
isk
Degree of Provider Integration and Accountability
Fee-for-service
Primary Care
Incentives
Performance-based
Contracts (PBC)
Bundled/Episode
Payments
Shared Savings
Shared Risk
Capitation + PBCOur modular set of value-based
payment models align with a
provider’s risk readiness.
Accountable Care Platform
Value-based Payment Models
Performance-based Programs
Centers of Excellence
Accountable
Care
Programs
© 2012 UnitedHealth Group. Any use, copying or distribution without written permission from UnitedHealth Group is prohibited.
How evidence is used to inform medical policy:
• Definition of a ―Covered Service‖ as a contract term
• Use of a defined, structured review process, with an explicit hierarchy of evidence
• Separate consideration of clinical efficacy and effectiveness (to determine whether the service is eligible for coverage) from costs and cost-effectiveness (to guide approaches to promoting optimal quality and affordability)
• Policy Context: Medical Technology innovation valuable, but also can contribute to high and rising health spending without commensurate clinical benefits (too much ―flat of the curve‖ health care)
• All stakeholders need better data to distinguish between ―high‖ and ―low‖ value services—for both populations and for individuals
• State of the Evidence: Often many unanswered questions
• Variation in the depth, breadth and quality of research needed to inform patients and physicians
• Variation in the quality, clarity and underlying evidence from clinical guidelines and other policy statements
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Common, Typical Questions:
• Does it work? How strong is the evidence?
• Is a proposed new treatment safe (relative to other available treatments and the natural history of the disease)?
• What specific populations would benefit ? What specific populations would not?
• How does the procedure, service, drug or device improve health outcomes?
• What are the advantages, harms and alternatives to the proposed treatment?
• What is the clinical evidence of effectiveness and safety of the proposed treatment?
• How does it work in the ―real world‖?
• Which study design will answer safety and effectiveness questions specific to the treatment under review?
• What questions can be addressed through retrospective observational series?
• What questions will prospective multi-site observational series answer?
• How do we consider the strength of the evidence (e.g. GRADE) vs. the strength of the recommendations?
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Creating Nuanced Clinical Policies (when the evidence is available!)
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Breast Cancer
Screening
Treatment
Colorectal Cancer
Screening
Treatment
Asthma
Diabetes
Hypertension
Cardiovascular
Disease
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Using Sophisticated Data and Analytics to Simplify and Synchronize:
Moving from reactive care to proactive care
Cell Phone
Personal Action Plan
Personalized tools, resources and information
Direct Mail
Holistic Member View
Personalized Portal, PHR,
Messages and Email
Onsite Resources,
Biometric Kiosks, etc.
Interactive Coaches,
Online Communities,
Tools and Trackers
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Providing Clinically Nuanced Outreach, Support, and Care Facilitation:
Care Managers proactively identify and prioritize opportunities in four major areas:
Powered by
Right Provider
Right Care
Right
Medication
Right
Lifestyle
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Creating the Future by Inventing It:
Need greater ―speed to answer‖ and ―speed to use‖
Speed to answer:
Understand the right questions earlier
Create a ―learning health system‖ where information is gathered, analyzed, disseminated as care is being delivered
Capitalize on the opportunities created by ―Big Data‖—sophisticated analysis of observational data
Increase use of modeling/simulation approaches
Speed to use:
Better dissemination; clinical decision support
Specialty society guidance, performance assessment and feedback
Benefit design and incentives e.g. Value-Based Benefits
Need for new (and large) data sets: phenotypes, functional status, patient-reported outcomes
Also continue to need prospective trials that are ―faster, better, cheaper‖
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We need to work together to promote high-value innovation!